US Health Regulators Investigating Complaints about Theranos’ Laboratory and research practices

“We trust our regulators to properly investigate any complaints, and we look forward to continuing our strong and productive relationships with them”, she added in the report.

A report in the Wall Street Journal has suggested that a beleaguered, multi-billion-dollar startup developing blood testing technology, Theranos Inc. has been under investigation by two federal agencies.

One of the ex-employees filed the complaint in September 2015 to the CMS accusing that the company’s upper management ordered laboratory employees to keep on using the proprietary blood testing technology of Theranos in spite of knowing that there were indications of major accuracy, stability and precision with those procedures.

Theranos gained prominence and drew skepticism earlier this year with claims that it could perform a multitude of medical tests with just a few drops of blood. This month saw another ex-employee of Theranos filing a fresh complaint with the US Food & Drug Administration for the company’s herpes test. According to this new complaint, Theranos’ herpes test is tainted by violation of research protocol. For example, in a test for thyroid hormone, which helps regulate the body’s metabolism, the Edison’s results would swing between showing a patient had hypothyroidism (too little hormone) to hyperthyroidism (too much hormone), the ex-employee said.

Theranos strongly claims that all its lab work is accurate and reliable.

Holmes fought back the claims stating the company has moved away from one of its devices only briefly as it transitions to getting approval from the FDA for all of its tests. It wouldn’t surprise us to see the FDA pull its support for the test before long. Recently, Elizabeth Holmes, the company’s founder and chief executive, defended Theranos in public appearances and even pledged to publish peer-reviewed data on its tests.